Immediate release abuse deterrent formulations

Abstract

The present invention provides immediate release abuse resistant or deterrent formulations such as ingestible dosage form articles suitable for the delivery of one or more medicaments or other active materials.

The invention claimed is: 
     
       1. An immediate release, abuse deterrent, pharmaceutical formulation comprising:
 an active ingredient formulated in a composition comprising: 
 from 40-80% w/w based on the total weight of the formulation of a carrier selected from the group comprising: poloxamers, polysorbates, polyethoxylates; polyethylene-glycols; and polyoxyl-glycerides; and combination thereof; and 
 from 20-60% w/w based on the total weight of the formulation of a high acyl gellan gum, where the composition does not contain a disintegrant. 
 
     
     
       2. The formulation according to  claim 1 , wherein the composition comprises from 50-80% w/w based on the total weight of the formulation of the carrier. 
     
     
       3. The formulation according to  claim 1 , wherein the composition comprises from 20-50% w/w based on the total weight of the formulation of a high acyl gellan gum. 
     
     
       4. The formulation according to  claim 1 , wherein the high acyl gellan gum has a weight average molecular weight of at least 5×10 5  Daltons. 
     
     
       5. The formulation according to  claim 1 , wherein the high acyl gellan gum has a set temperature of between 70 and 80° C. 
     
     
       6. The formulation according to  claim 1 , further comprising at least one other pharmaceutically acceptable excipient. 
     
     
       7. The formulation according to  claim 1 , wherein the active ingredient is an opioid and at least 70% of the opioid is released within 60 minutes in a USP Apparatus I, II or III in a relevant dissolution medium. 
     
     
       8. The formulation according to  claim 1 , wherein the active ingredient is susceptible to abuse. 
     
     
       9. The formulation according to  claim 8 , wherein the active ingredient is at least one active ingredient selected from opioids and morphine derivatives; antidepressants; stimulants; hallucinogenics; hypnotics; and tranquilizers, amphetamine, alprazolam, codeine, diazepam, fentanyl and analogs thereof, hydrocodone, hydromorphone HCI, lorazepam, meperidine, morphine, methylphenidate, methadone, nitrazepam, oxycodone HCL, oxymorphone, propoxyphene, temazepam, tramadol, zolpidem, and zopiclone. 
     
     
       10. The formulation according to  claim 1 , wherein the active ingredient is present in an amount ranging from about 0.05% w/w to about 30% w/w based on the total weight of the formulation. 
     
     
       11. The formulation of  claim 1  having a viscosity of greater than 5000 cp. 
     
     
       12. A formulation according to  claim 1 , in a hard shell capsule, a gelatin capsule, or an hydroxypropyl methyl cellulose (HPMC) capsule. 
     
     
       13. The formulation according to  claim 1 , wherein the composition comprises from 60-80% w/w based on the total weight of the formulation of the carrier. 
     
     
       14. The formulation according to  claim 1 , wherein the composition comprises from 20-40% w/w based on the total weight of the formulation of a high acyl gellan gum. 
     
     
       15. The formulation according to  claim 1 , wherein the active ingredient is present in an amount ranging from about 0.05% w/w to about 20% w/w, based on the total weight of the formulation. 
     
     
       16. The formulation according to  claim 1 , wherein the active ingredient is present in an amount ranging from about 0.05% w/w to about 10% w/w based on the total weight of the formulation. 
     
     
       17. The formulation according to any of  claim 1 ,  2 - 5  or  12 - 16 , wherein the active ingredient consists of at least one active ingredient selected from opioids and morphine derivatives; antidepressants; hypnotics; and tranquilizers, alprazolam, codeine, diazepam, fentanyl and analogs thereof, hydrocodone, hydromorphone HCI, lorazepam, meperidine, morphine, methylphenidate, methadone, nitrazepam, oxycodone HCL, oxymorphone, propoxyphene, temazepam, tramadol, zolpidem, and zopiclone.